A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

COVID-19 Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884554
• Other study ID #: C5091014
• Status: Recruiting
• Phase: Phase 1
• Start date: June 15, 2023
• Est. completion date: October 16, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.

This study is seeking participants who:

• are male or female of 18- 75 years of age

• either have different amounts of damage to liver function or for one of the groups, no damage

• willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days

About, 6-8 participants will be selected in groups 1, 2 and 3. In group 4, around 4 to 8 participants will be selected.

If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) atleast 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.

The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 16, 2024
• Est. primary completion date: October 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification;

• (all Cohorts): BMI of 17.5 to 38.0 kg/m2

Exclusion Criteria:

• Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only

• Limited predicted life expectancy

• Hepatic dysfunction secondary to acute ongoing hepatocellular process.

• Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy.

• Severe ascites and/or pleural effusion

• History of kidney, liver, or heart transplantation.

• Persistent severe, uncontrolled hypertension.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• PF-07817883
Experimental

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	National Institute of Clinical Research	Garden Grove	California
United States	Research Centers of America	Hollywood	Florida
United States	Research Centers of America ( Hollywood )	Hollywood	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	Genesis Clinical Research, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-07817883	Plasma PF-07817883 PK parameters	Day 1 to Day 6
Primary	Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)	Plasma PF-07817883 PK parameter	Day 1 to Day 6
Primary	Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)	(Optional) Plasma PF-07817883 parameter	Day 1 to Day 6
Secondary	Number of Participants with Non-Serious Adverse Events	Safety Parameters	Screening to Day 35
Secondary	Number of Participants with Treatment Emergent Adverse Events	Safety Parameters	Day 1 to Day 35
Secondary	Number of Participants with Clinically Significant ECG Abnormalities	ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate	Day 1 to Day 6
Secondary	Number of Participants with Clinically Significant Abnormal Vital Signs	Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate	Day 1 to Day 6
Secondary	Number of Participants with Clinically Significant Abnormal Laboratory Values	Blood hematology and Chemistry and Urinalysis	Baseline to Day 6
Secondary	Number of Participants with Serious Adverse Events	Safety Parameters	Screening to Day 35

External Links

•   To obtain contact information for a study center near you, click here.